AB1149 EVALUATION OF THE EFFICACY AND SAFETY OF THE SARS-CoV-2 VACCINE IN PATIENTS WITH CHRONIC INFLAMMATORY DISEASES TREATED WITH BIOLOGICAL THERAPY.
Authors: J. Calvo Gutierrez, C. López-Medina, M. C. Ábalos-Aguilera, A. B. Pérez Jiménez, D. Ruíz-Vilchez, F. U. Pilar, R. Ortega Castro, A. Escudero Contreras, E. Collantes Estevez
Journal: Annals of the Rheumatic Diseases (2022)

Background In the current situation of the SARS-CoV-2 pandemic, the Spanish Society of Rheumatology recommends vaccination of patients with chronic inflammatory diseases (CID) under treatment with biological DMARDs (bDMARDs). However, the data regarding the generation of protective antibody titers after mRNA vaccines in patients with CID is limited. Objectives To determine the seroconversion rate and safety after the SARS-CoV-2 vaccine in patients with CID under treatment with bDMARDs Methods Cross-sectional observational study of 81 patients with CID from the HURS in Córdoba, who have received full vaccination for SARS-CoV-2 (without having previously suffered from COVID-19 disease) according to national guidelines. A determination of specific IgG-type antibodies against the trimeric spike protein of SARS-CoV2 was performed on all of them. The chemiluminescence technique with the kit was used in serum samples taken 4-5 weeks after administration of the second dose of the vaccine. Information about sociodemographic characteristics, disease, type of bDMARDs, concomitant treatments and adverse effects after the second dose of the vaccine were collected in each patient. Results 81 patients were included (mean age 59.5, 72.8% females). 50.6% of patients had RA, 17.3% SpA, 11% PsoA and 18.5% other CID. 23.5% were under treatment with Rituximab, 38.8% antiTNF, 13.6% Tocilizumab, 9.9% abatacept, 5% anti-JAK and 14.2% under other treatments. Anti-SARS-CoV-2 antibodies and neutralizing activity were detected in 80% of study participants. Rituximab treatment was significantly associated with negative seroconversion in comparison with patients under antiTNF treatment (OR 84.0 (95%CI 12.9-1709.2)). No interaction was found between the bDMARDs treatment and the type of vaccine with regard to the seroconversion, nor between bDMARDs and concomitant synthetic DMARD. When we evaluated IgG titers against the spike protein of SARS-CoV2, we found that patients under treatment with Rituximab showed the lowest titers levels in comparison with patients with other treatments (Figure 1, Table 1). In addition, patients who received AstraZeneca vaccine developed lower titers of antibodies in comparison with patients who received Pfizer (Table 1). Table 1. Linear regressions to evaluate the IgG titers and their association with the bDMARD and the type of vaccine. Beta Coefficient (95% CI ) IgG titers p-value bDMARD Reference - Anti-TNF -405.6 (-893.7 to 82.4) - Anti-IL6 -728.7 (-1133.8 to -323.5) 0.102 - Rituximab 88.7 (-462.8 to 640.1) &lt;0.001 - Abatacept 315.6 (-423.2 to 1054.4) 0.749 - Anti-JAK 256.3 (-482.5 to 995.1) 0.397 - Otros 0.491 Vaccine - Pfizer Reference - AstraZeneca -408.6 (-804.6 to-12.6) 0.043 - Janssen - 783.4 (-1662.1 to 95.3) 0.08 - Moderna 130.6 (-407.5 to 668.7) 0.63 Methotrexate* bDMARD 27.3 (-215.3 to 269.9) 0.823 Leflunomide* bDMARD 208.0 (-188.9 to 604.9) 0.300 Corticosteroides* bDMARD 32.9 (-259.4 to 325.2) 0.823 Vaccine* bDMARD 4.2 (-106.1 to114.6) 0.939 Figure 1. IgG titers against the spike protein of SARS-CoV2 with regard to the bDMARD Interestingly, among patients with antiTNF treatment, AstraZeneca was associated with lower IgG titers in comparison with Pfizer and Moderna [405.9 (553.0) vs. 1084.1 (791.2) vs. 1264.0 (1012.6), p=0.016, respectively]. No differences between vaccines were found in patients with the other type of bDMARDs. Only 18.9% presented mild adverse effects. No serious adverse effects were observed and no patient experienced a disease flare after vaccination. Conclusion Our results show that SARS-CoV-2 mRNA vaccines produce seroconversion in most patients with CID, except in the case of patients with rituximab. No severe adverse effects or CID reactivation were found. Despite the small number of patients included, this study suggests the need for revaccination in the group of patients treated with rituximab or vaccinated with Astrazeneca. Disclosure of Interests None declared